MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-16 for ABBOTT M2000SP 09K14-001 manufactured by Abbott Molecular, Inc..
[2984880]
A customer at the (b)(6) hospital ((b)(6)) reported that a laboratory technician was splashed in one eye when disconnecting the liquid waste container on the m2000sp instrument. The waste container was being emptied as part of the instrument weekly maintenance. The splash occurred as the waste container lid was being removed. The technician was wearing a lab coat and gloves at the time of exposure. One of the technician's gloves caught on the connector on top of the lid. Liquid waste was flicked up as the lid was being tuned and as the glove was freed from the connector. The technician's eye was immediately rinsed. The technician went to the hospital emergency room to receive medical attention. Additional information as follows was provided: the technician received a hbv vaccination for prophylaxis; the technician's eye was not damaged; the technician elected to take 1 dose of hiv post-exposure prophylaxis (pep); however subsequently opted to not continue with the pep.
Patient Sequence No: 1, Text Type: D, B5
[10264475]
By failing to wear protective eyewear, the laboratory technician did not follow good laboratory practices and instructions provided in the m2000sp operations manual for emptying the m2000sp liquid waste container. The m2000sp operations manual 200681-105-october 2011 contains the following labeling: user or function - liquid waste container. Caution: the waste is potentially infectious. Use appropriate biohazard precautions. Waste handling and disposal - liquid waste. Warning: the liquid waste may contain infectious agents and should be considered potentially infectious waste. Daily maintenance: service and maintenance - empty liquid waste container warning: potential biohazard. Instrument waste could be contaminated with potentially infectious materials. Observe basic biohazard precautions. Wear appropriate personal protective equipment such as gloves, lab coats, and protective eyewear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2012-00019 |
| MDR Report Key | 2853092 |
| Report Source | 07 |
| Date Received | 2012-07-16 |
| Date of Report | 2012-06-26 |
| Date of Event | 2012-06-22 |
| Date Mfgr Received | 2012-06-26 |
| Date Added to Maude | 2012-12-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2123617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000SP |
| Product Code | JQW |
| Date Received | 2012-07-16 |
| Catalog Number | 09K14-001 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-16 |